Somatropin Biopartners

Lapsed

This medicine's authorisation has lapsed

somatropin

Overview

On 9 November 2017, the marketing authorisation of Somatropin Biopartners (somatropin) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, BioPartners GmbH, had not marketed Somatropin Biopartners in the EU since its initial marketing authorisation. 

In accordance with the provisions of Article 14(4) of Regulation (EC) No 726/2004 ("sunset clause"), the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. The European Commission had granted an exemption from the ‘sunset clause’ for Somatropin Biopartners; however the exemption expired on 8 November 2017. BioPartners GmbH confirmed that the product had not been marketed as they were unable to supply it. Somatropin Biopartners was granted marketing authorisation in the EU on 5 August 2013 for the replacement therapy of endogenous growth hormone in adults with growth hormone deficiency. 

The European Public Assessment Report (EPAR) for Somatropin Biopartners is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Somatropin Biopartners : EPAR - Summary for the public

Reference Number: EMA/338086/2013

Product information

Somatropin Biopartners : EPAR - Product Information

Somatropin Biopartners : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Somatropin Biopartners
• Active substance:
  somatropin
• International non-proprietary name (INN) or common name:
  somatropin
• Therapeutic area (MeSH):
  Growth
• Anatomical therapeutic chemical (ATC) code:
  H01AC01

Pharmacotherapeutic group

• Somatropin and somatropin agonists
• Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Somatropin Biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (GHD).

Adult-onset: Patients with GHD in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a GHD.

Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (< -2 standard-deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.

Authorisation details

• EMA product number:
  EMEA/H/C/002196
• Marketing authorisation holder:
  BioPartners GmbH

  Kaiserpassage 11; D-72764 Reutlingen; Germany

• Marketing authorisation issued:
  05/08/2013
• Lapse of marketing authorisation:
  09/11/2017
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Somatropin Biopartners : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Somatropin Biopartners : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/229458/2013